Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
About this trial
This is an interventional supportive care trial for Stage IIIB Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Advanced (stage IIIB or IV) non-small cell lung cancer diagnosed by biopsy of the primary or metastatic site (American Joint Committee on Cancer 7.0)
- No known presence of known EGFR or EML4-ALK driver mutations in the tumor
- Started first-line systemic therapy of the investigator's choice within 12 weeks prior to registration, or planning to initiate first-line systemic therapy of the investigator's choice within 4 weeks after registration; no planned initiation of definitive (potentially curative) concurrent chemo-radiation
- No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy (other than current treatment); prior palliative radiation permitted; prior adjuvant systemic therapy /radiation is permitted
- No more than 7 days of prior use of mixed opioid agonist/opioid antagonists or other opioid antagonists within 4 weeks before registration; patients should not receive such medications after registration and for the entire duration of study treatment
- No methadone within 4 weeks prior to registration
- Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration; current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required
- Expected survival > 3 months
- No concurrently active second invasive malignancies except non-melanoma skin cancer
- No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall; no abdominal surgery within 60 days of registration
- No acute gastrointestinal conditions, such as: obstruction, fecal impaction, obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel movements (such as digital evacuation)
No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer's disease, or uncontrolled seizures)
- No symptomatic and untreated brain metastases; patients will be eligible for study if radiation therapy for brain metastases was completed at least 7 days prior to registration
- Patients having received stereotactic radiation will be eligible if the radiation was completed at least 7 days prior to registration
- Patients having undergone surgical resection of brain metastases will be eligible after they have healed and recovered from the surgical intervention sufficiently to start systemic treatment for NSCLC, as determined by a neurosurgeon
- No known leptomeningeal carcinomatosis
- No history of myocardial infarction =< 6 months prior to registration; no current symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac arrhythmias
- No severe hepatic impairment (Child-Pugh class C) or acute liver disease
- No known serious or severe hypersensitivity reaction to naloxegol or any of its excipients
- No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers
- Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Calculated (calc.) creatinine clearance >= 60 mL/min calculated using the Cockcroft-Gault formula
- Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert's disease
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Kingman Regional Medical Center
- CHI Saint Vincent Cancer Center Hot Springs
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Mission Hope Medical Oncology - Arroyo Grande
- PCR Oncology
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Tibor Rubin VA Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- USC Norris Oncology/Hematology-Newport Beach
- Keck Medical Center of USC Pasadena
- Mission Hope Medical Oncology - Santa Maria
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Cancer Center of Colorado at Sloan's Lake
- Denver Health Medical Center
- Kaiser Permanente-Franklin
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Mountain Blue Cancer Care Center
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Good Samaritan Medical Center
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Middlesex Hospital
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- Holy Cross Hospital
- Broward Health Medical Center
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Memorial Hospital West
- South Florida Baptist Hospital
- Saint Anthony's Hospital Cancer Care Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Low Country Cancer Care Associates PC
- Summit Cancer Care-Candler
- Hawaii Cancer Care - Savio
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc-POB II
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Medical Center
- Walter Knox Memorial Hospital
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Mountain States Tumor Institute - Nampa
- Kootenai Cancer Center
- Kootenai Cancer Clinic
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- University of Illinois
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Joliet Oncology-Hematology Associates Limited
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- West Suburban Medical Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Memorial Regional Cancer Center Day Road
- Reid Health
- Memorial Hospital of South Bend
- Mary Greeley Medical Center
- McFarland Clinic PC - Ames
- McFarland Clinic PC-Boone
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- McFarland Clinic PC-Trinity Cancer Center
- Trinity Regional Medical Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Siouxland Regional Cancer Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- HaysMed University of Kansas Health System
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Cancer Center of Kansas - Parsons
- Ascension Via Christi - Pittsburg
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- Cancer Center of Kansas - Wellington
- University of Kansas Hospital-Westwood Cancer Center
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Hardin Memorial Hospital
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center Northeast
- Saint Claire Regional Medical Center
- Jewish Hospital Medical Center South
- Beverly Hospital
- Addison Gilbert Hospital
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Mercy Medical Center
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- IHA Hematology Oncology Consultants-Brighton
- Saint Joseph Mercy Brighton
- IHA Hematology Oncology Consultants-Canton
- Saint Joseph Mercy Canton
- Caro Cancer Center
- IHA Hematology Oncology Consultants-Chelsea
- Saint Joseph Mercy Chelsea
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Beaumont Hospital - Dearborn
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Michigan State University Clinical Center
- Green Bay Oncology - Escanaba
- Beaumont Hospital - Farmington Hills
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- William Beaumont Hospital-Grosse Point
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- McLaren-Greater Lansing
- Sparrow Hospital
- Hope Cancer Clinic
- Saint Mary Mercy Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Huron Medical Center PC
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Michigan Cancer Specialists
- Oakland Colon and Rectal Association
- Cancer Care Associates PC
- Comprehensive Medical Center PLLC
- Hematology Oncology Consultants PC
- Oakland Medical Group
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Bhadresh Nayak MD PC-Sterling Heights
- Premier Hematology Oncology Care
- Mitchell Folbe MD PC
- Ascension Saint Joseph Hospital
- Munson Medical Center
- Michigan Institute of Urology-Town Center
- Claudia BR Herke MD PC
- William Beaumont Hospital - Troy
- Hematology Oncology Consultants PC-Troy
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Metro Health Hospital
- Huron Gastroenterology PC
- IHA Hematology Oncology Consultants-Ann Arbor
- Riverwood Healthcare Center
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Minneapolis VA Medical Center
- Health Partners Inc
- University of Minnesota/Masonic Cancer Center
- Monticello Cancer Center
- New Ulm Medical Center
- Essentia Health - Park Rapids
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
- Baptist Cancer Center-Grenada
- University of Mississippi Medical Center
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Parkland Health Center-Bonne Terre
- Saint Francis Medical Center
- Southeast Cancer Center
- Parkland Health Center - Farmington
- Capital Region Southwest Campus
- Truman Medical Centers
- Kansas City Veterans Affairs Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital
- Missouri Baptist Medical Center
- Sainte Genevieve County Memorial Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at Oakey
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Radiation Oncology Centers of Nevada Southeast
- 21st Century Oncology-Vegas Tenaya
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainView
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- Urology Specialists of Nevada - Southwest
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- New Hampshire Oncology Hematology PA-Concord
- New Hampshire Oncology Hematology PA-Hooksett
- The Dana-Farber Cancer Institute at Londonderry
- Hematology Oncology Associates of Central New York-Auburn
- Northwell Health Imbert Cancer Center
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- Hematology Oncology Associates of Central New York-East Syracuse
- Arnot Ogden Medical Center/Falck Cancer Center
- Northwell Health/Center for Advanced Medicine
- Rochester General Hospital
- University of Rochester
- Stony Brook University Medical Center
- Hematology Oncology Associates of Central New York-Onondaga Hill
- Southeastern Medical Oncology Center-Clinton
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Margaret R Pardee Memorial Hospital
- Maria Parham Hospital
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- Scotland Memorial Hospital-Laurinburg Cancer Center
- Southeastern Regional Medical Center
- Vidant Oncology-Richlands
- WG Hefner VA Medical Center
- Johnston Memorial Hospital
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford South University Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Essentia Health - Jamestown Clinic
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Saint Elizabeth Boardman Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Adena Regional Medical Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Mount Carmel Grove City Hospital
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Fairfield Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- Saint Joseph Warren Hospital
- Saint Ann's Hospital
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Lehigh Valley Hospital - Muhlenberg
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Pocono Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Lehigh Valley Hospital-Hazleton
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Geisinger Cancer Services-Pottsville
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- Prisma Health Cancer Institute - Laurens
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Prisma Health Cancer Institute - Spartanburg
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Baptist Memorial Hospital and Cancer Center-Memphis
- Memorial GYN Plus
- Saint Joseph Regional Cancer Center
- Dallas VA Medical Center
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Augusta Health Center for Cancer and Blood Disorders
- Providence Regional Cancer System-Aberdeen
- MultiCare Auburn Medical Center
- Overlake Hospital Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Valley Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- Swedish Medical Center-Cherry Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Mary Bridge Children's Hospital and Health Center
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Providence Regional Cancer System-Yelm
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Medical Center-EC Cancer Center
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Saint Vincent Hospital Cancer Center at Marinette
- Marshfield Medical Center-Marshfield
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Clinic Stevens Point Center
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Clinic - Weston Center
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Group I (lower dose naloxegol, placebo)
Group II (placebo, higher dose naloxegol)
Group III (placebo)
Patients receive lower dose naloxegol PO QD and placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.